HTA & Medical Devices: An International Perspective

1. HTA & Medical Devices:An InternationalPerspective Christina Farup, MD, MS | April 2015

2. Definition of HTA Health Technology Assessment...is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focused and seek to achieve best value • EUnetHTA: http://www.eunethta.eu/about-us/faq#t287n73 Key Considerations -What is the purpose of the HTA? How are devices reimbursed? -Are all devices alike and should be they treated as all the same or like drugs? -Who can best evaluate and translate the value of a device in the healthcare system and delivery of care? -When and how should evidence evolve for devices?

3. Class III Class IIb Class IIa Class I

4. European HTA - 2000 European INAHTA members 2000 1 1 2 4 4 1 1 1 1 4 2 2 4

5. European HTA – 2013 2 1 6 3 3 4 1 5 12 1 5 9 2 2 1 2 7 5 9 2 3 1 6 2 3 12 2 3 1 1 1

6. Introduction to HEMA, Asia Pacific, August 2011 HTA in Asia Pacific AUSTRALIA JAPAN CHINA Department of Preventive Medicine, University of Tokushima, Japan Adelaide Health Technology Assessment (AHTA), Australia Medical Services Advisory Committee (MSAC), Australia, since 1998 HTA Key Lab of MOH, WHO Collaboration Center (Fudan University) TAIWAN Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S), Australia HTA Division, Health Policy Development & Research Center of MOH CDE Center for Drug Evaluation, Taiwan, since 2007 HTA Division, HTA Research Office of China Medical Academy Australia and New Zealand Horizon Scanning Network (ANZHSN), Australia HONG KONG Pharmacoeconimics Centers: Peking University, Fudan University, Pharmaceutical Association Office of Technology Management, Hong Kong, since NEW ZEALAND MALAYSIA SOUTH KOREA New Zealand Health Technology Assessment (NZHTA), New Zealand, since 1997 Kementerian Kesihatan Malaysia (KKM), Malaysia National Evidence-based Healthcare Collaborating Agency, South Korea SINGAPORE Clinical Standards and Technology Assessment (CSTA) branch at the Singapore Ministry of Health, Singapore THAILAND National Health Security Office, Thailand, since 2002 PHILIPPINES INDONESIA HTA Committee of the PhilHealth, Philippines, since 1999 Center for Health Services Research and Development, Indonesia,

7. HTA in US= Hospital Value Assessment Committee Submit requests for new products Assemble available clinical and financial data Provide subject-matter expertise and opinion of products’ clinical benefits Surgeon Hospital Level Review all available clinical and cost data Preform CER using hospital-specific data Recommends approval or denial of request System Level Collect available data Preform CER Negotiate vendor and GPO contracts OR Clinicians Hospital & System Level Assess strategic benefit to department, hospital, or system Prioritize hospital and system investments Set cost reduction & containment targets for materials management Surgical Services Director COO Materials Management Director Chief of Surgery Finance Director CFO Supply Chain Director

8. US VACs weigh the clinical, financial, and strategic benefits of new surgical products and services against the cost of adoption

9. Some “Take-away” thoughtsThe future potential to improve best practice • Aspects of device value are varied • HTA assessment of value • Hospital assessment of value • Limitations to both • New solutions for evidence development • -affordable, practical, flexible when appropriate • More debate on when, who, why for HTA=“fit for purpose” • -more dialogue with key stakeholders: Surgeons, Providers, Industry, Patients